NCT00510367 is a EARLY_PHASE1 clinical trial of 5-Fluorouracil in Breast Cancer, sponsored by M.D. Anderson Cancer Center.

Who is sponsoring NCT00510367?

NCT00510367 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT00510367?

Interventions in NCT00510367: 5-Fluorouracil, Cyclophosphamide, Doxorubicin.

What condition does NCT00510367 study?

NCT00510367 studies Breast Cancer, Pregnancy.

Is NCT00510367 still recruiting?

NCT00510367 is currently completed. Last updated 10 July 2020.

Last reviewed 2020-07-10 · How we verify

NCT00510367

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Primary Breast Cancer Occurring Concomitant With Pregnancy

Completed EARLY_PHASE1 Last updated 10 July 2020

What this trial tests

EARLY_PHASE1 trial testing 5-Fluorouracil in Breast Cancer in 61 participants. Completed in 8 July 2020.

Timeline

7 August 2001

Primary endpoint
8 July 2020

8 July 2020

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	7 August 2001
Primary completion	8 July 2020
Estimated completion	8 July 2020
Sites	1 location across United States

Drugs / interventions tested

5-Fluorouracil
Cyclophosphamide (cyclophosphamide) — full drug profile →
Doxorubicin (doxorubicin) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Pregnancy — all drugs for Pregnancy →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Eligibility, female only, with Breast Cancer or Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical research study is to learn the results of multimodality (chemotherapy, surgery and radiation therapy) treatment of primary breast cancer that occurs at the same time as pregnancy. Researchers want to evaluate the outcome of labor and delivery as well as evaluate the long-term health outcomes of children exposed to chemotherapy while in their mother's womb.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Outcomes of children exposed in utero to chemotherapy for breast cancer.
Murthy RK, Theriault RL, Barnett CM, Hodge S, et al · · 2014 · cited 59× · PMID 25547133 · DOI 10.1186/s13058-014-0500-0

Verify or expand the search:

Other trials of 5-Fluorouracil

Trials testing the same drug.

NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial) · Phase 2 · not yet recruiting
NCT07059611 — Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma · Phase 2 · not yet recruiting
NCT07441369 — Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer · Phase 2 · enrolling by invitation
NCT07431281 — Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Meta · Phase 3 · recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00510367 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 10 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00510367.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing